What are the steps involved in a study?
Perhaps you were approached by your doctor, nurse or other Health Care Professional about a clinical trial that may be suitable for you. Or perhaps you answered an advert looking for people to take part in a study. In either case, the process will be similar, involving the following main stages:
Initial discussion: this will usually take place with a nurse or doctor at the research site (hospital or GP surgery) who will explain
- the purpose of the study
- what kind of patients they are looking to include in the study
- what you would be expected to do during the study
- what measurements or procedures would be involved
- what the possible benefits and risks would be
- and how long the trial would go on for. If you are interested in taking part you will then receive written information about the trial which you can take away and think about.
Consent: having read all the study information, if you feel you would like to take part in the study you then come back to the research centre and sign a form agreeing to take part in the study
Screening phase: some trials include a a period of a few days or weeks at the start of the trial where you the study team will just take some measurements to confirm whether or not you match all the things needed to to join the trial. For example you might need to have your blood pressure measured at two or three different visits to confirm that it is usually above or below a certain level.
Randomisaton: at the end of the screening period, if you match all the factors needed for taking part in the trial and would like to start the trial, you will then enter the treatment phase. If the trial is comparing different treatments, a certain proportion of people in the trial will be given each of the treatments. This might mean half get Treatment A and the other half get Treatment B, but sometimes the numbers of people in each group are unequal. If the trial is a blinded trial, this means that the study team or the patient (or both) should not know which treatment you will be taking.
Treatment phase: you then continue the trial treatment for the period stated in the trial protocol (instructions) while visiting the research centre at regular intervals to see how you are getting on. The duration of the treatment phase differs considerably from trial to trial and depends to a large extent on the therapy area. Some trials can be as short as one day while others can go on for years.
Follow up phase: there may be an additional period at the end of the treatment phase where the research team will continue to monitor you and assess whether the treatment has been successful.
Analysis and publication of results: when all the patients in the trial have completed the treatment, the results will be analysed and the results will then be published in a scientific journal. You can request a copy of the results from your study team.